- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427152
Pre-meal Planning and Expected Satiety
May 29, 2017 updated by: University Hospital Tuebingen
Obesity is considered to be caused by an imbalance between energy expenditure and energy intake.
A major determinant of our daily energy intake is the size of the meals that we consume.
It has been suggested that decisions about portion sizes are often made in advance, before a meal begins.
This pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods.
Further, also factors like weight concern and palatability of the food might have their influence on meal size selection.
In general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process.
Thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences.
The investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors.
Further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health.
Finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tuebingen, Germany, 72076
- Recruiting
- University Clinic of Tuebingen, fMEG Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
lean and overweight/obese healthy volunteers
Description
Inclusion Criteria:
- body mass index: 18-25 kg/m²; 25-35 kg/m²,
- right-handed,
- age: 18-35 years.
Exclusion Criteria:
- functional magnetic resonance imaging contraindications,
- claustrophobia,
- self-reported eating disorders,
- vegan or vegetarian diet, food allergies,
- intake of antidepressants,
- metabolic disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Lean
body mass index: 18-25 kg/m²
|
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Overweight/Obese
body mass index: >25 kg/m²
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differential brain functions in reward, decision making and inhibitory control networks (brain functions will be measured by blood oxygen level dependent effects)
Time Frame: day 0
|
brain functions will be measured by blood oxygen level dependent effects
|
day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Differential behavioral measures of portion size selection
Time Frame: day 0
|
day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
April 24, 2015
First Posted (Estimate)
April 27, 2015
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 29, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Satt
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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